Contraindications:
Do not take Reclofenac 50 mg, if you are allergic to diclofenac sodium or to any of the other ingredients of Reclofenac 50 mg gastro-resistant capsules.

If you have active, or history of recurrent gastrointestinal ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding.

If you have reacted in the past after taking acetylsalicylic acid or other NSAIDS with asthma attacks, swelling of the nasal mucous membranes, or skin reactions in the presence of unexplained blood formation disorders.

If you have history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

If you have cerebral hemorrhage (cerebrovascular bleeding) or other active bleeding disorders.

If you have severe impairment of liver or kidney function.

If you suffer from severe heart failure.

If you have established heart disease and /or cerebrovascular disease e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or blockages to blood vessels to the heart or brain or an operation to clear or bypass blockages. If you have or have had problems with your blood circulation (peripheral arterial disease).

If you are in the last three months of pregnancy.

Side effects

Like all medicines, this medicine can cause side effects. If you should experience any of the following side effects, please discuss them with your doctor, who will then decide what to do next.
The following frequency data are normally used for evaluating side effects:

Very common

more than 1 user in 10

Common

1 to 10 users in 100

Uncommon

1 to 10 users in 1,000

Rare

1 to 10 users in 10,000

Very rare

less than 1 user in 10,000

Not known

frequency cannot be estimated from the available data

Possible side effects

It must be remembered that the following adverse drug reactions are mainly dose-dependent and can vary from patient to patient. The most commonly observed side effects involve the digestive tract. Gastroduodenal ulcers (peptic ulcers), perforation or bleeding – sometimes fatal – may occur, particularly in elderly patients. The following have been reported after Reclofenac administration: nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, blood vomiting, ulcerative stomatitis and worsening colitis and Crohn’s disease. Less commonly, inflammation of the stomach lining has been observed. In particular, the risk of gastrointestinal bleeding depends on the dosage range and duration of treatment. Oedema, high blood pressure and heart failure have been reported in association with NSAID treatment. Medicines like Reclofenac 50 mg may be associated with a slightly higher risk of heart attack (“myocardial infarction”) or stroke.

Cardiac disorders

Blood and lymphatic system disorders

Very rare: blood formation disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs may include: fever, sore throat, superficial lesions in the mouth, influenza-like symptoms, severe abnormal tiredness, nosebleeds and skin bleeding. In such cases, you must stop taking the medicine immediately and consult your doctor. You should never attempt to treat such disorders yourself with painkillers or fever-reducing drugs. Your blood count should be regularly monitored during long-term therapy. Very rare: haemolytic anaemia (caused by an accelerated breakdown of red blood cells) or aplastic anaemia (caused by a blood formation disorder) may occur.

Eye disorders

Ear and labyrinth disorders

Gastrointestinal disorders

Very common: gastrointestinal disorders such as nausea, vomiting and diarrhoea, as well as slight gastrointestinal blood loss, which in exceptional cases can cause anaemia. Common: indigestion (dyspepsia), bloating (flatulence), abdominal cramps, loss of appetite and gastrointestinal ulcers (with bleeding and perforation in some cases). Uncommon: gastritis, bloody vomiting (haematemesis), blood in the stools or bloody diarrhoea, stomach and intestinal ulcers. If you experience quite severe pain in the upper abdomen, blackening of the stools or blood in the stools, you must stop taking Reclofenac 50 mg and tell your doctor immediately. Very rare: inflammation of the mouth lining, inflamed tongue, oesophageal lesions (damage to the gullet), constipation and lower abdominal complaints, e.g. bleeding and inflamed colon, worsening ulcerative colitis or Crohn’s disease (types of colon inflammation accompanied by ulcers), inflamed pancreas (pancreatitis). Very rare: narrowing of the bowel has been reported.

Renal and urinary disorders

Uncommon: development of oedema (water retention in the body), especially in patients with high blood pressure or impaired kidney function. Very rare: damage to kidney tissue (interstitial nephritis, papillary necrosis), which may be associated with acute kidney dysfunction (kidney failure), protein in the urine (proteinuria) and/or blood in the urine (haematuria); nephrotic syndrome (water retention in the body [oedema] and excessive excretion of protein in the urine). Reduced urine output, water retention in the body (oedema) and feeling generally ill may be signs of kidney disease or even kidney failure. If these symptoms occur or get worse, you must stop taking Reclofenac 50 mg and contact your doctor immediately.

Infections and infestations

Very rare: worsening infection-related inflammation (e.g. development of necrotising fasciitis) has been described in temporal association with the use of specific anti-inflammatory agents (non-steroidal anti-inflammatory drugs, to which Reclofenac 50 mg also belongs). For this reason, you should consult a doctor immediately if signs of infection (e.g. redness, swelling, excessive heat, pain, fever) appear or get worse during use of Reclofenac 50 mg. Very rare: symptoms of aseptic meningitis, e.g. severe headache, nausea, vomiting, fever, stiff neck or reduced consciousness, have been observed during use of Reclofenac. There seems to be a higher risk for patients already suffering from certain autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease).

Vascular disorders

Very rare: high blood pressure (hypertension), inflammation of the blood vessels (vasculitis).

Respiratory disorders

Rare: asthma Very rare: inflammation of the lung (pneumonitis)

Immune system disorders

Rare: Hypersensitivity reactions are possible and may manifest as fall in blood pressure, heart racing and life-threatening shock. Very rare: Oedema which may manifest as swelling of the face, tongue or inner larynx with constriction of the airways, shortness of breath possibly leading to asthma attack. If any of these symptoms occur, which is possible even the first time the medicinal product is used, immediate medical attention is necessary. In these cases the medicine must be stopped at once and the doctor consulted.

Hepatobiliary disorders (liver and gallbladder)

Common: increase in the liver function values in the blood (serum transaminases). Rare: inflammation of the liver with or without jaundice, in very rare cases taking a very severe [fulminant] course, even without previous warning signs. Very rare: hepatic necrosis, liver damage, especially with long term treatment.

Psychiatric disorders

Always follow the procedures given above regarding what to do in the event of certain side effects.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Warnings and precautions

This section tells you when certain conditions apply when taking Reclofenac 50 mg (i.e. at longer dosing intervals or reduced doses, whilst under medical supervision). Even then, particular caution is required. Please ask your doctor for more information. This section is also relevant if the following information has ever applied to you in the past.

Gastrointestinal safety

Combined use of Reclofenac 50 mg and other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors), should be avoided.

Elderly patients:In elderly patients, incidence of side effects is more common after use of NSAIDs, particularly gastrointestinal bleeding and perforation, which can be life-threatening in some cases. Elderly patients should therefore be kept under particularly close medical monitoring. It is recommended that the lowest effective dose should be used in frail elderly patients or those with a low body weight.

Gastrointestinal bleeding, ulcers and perforation:Gastrointestinal bleeding, ulcers and perforation, some with a fatal outcome, have been reported with all NSAIDs. Such effects occurred at any time during therapy, with or without previous warning symptoms or a history of serious gastrointestinal events.The risk of gastrointestinal bleeding, ulcers and perforation increases with the NSAID dose in patients with a history of ulcers, especially with complications of bleeding or perforation (see section 2: “Do not use Reclofenac 50 mg”) and in elderly patients. These patients should start treatment at the lowest available dose. For these patients, as well as patients requiring additional treatment with low-dose acetylsalicylic acid (ASA) or other medicines that can increase the risk of gastrointestinal disorders, combined treatment with medications that protect the stomach lining (e.g. misoprostol or proton pump inhibitors) should be considered.

If you have a history of gastrointestinal side effects – particularly if you are elderly – you should report all unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the start of therapy. Caution is advised if you are also taking other medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants e.g. warfarin, selective serotonin reuptake inhibitors that are used to treat disorders including depression) or platelet aggregation inhibitors such as ASA (see section 2: “Other medicines and Reclofenac 50 mg”).

Treatment must be stopped if you develop gastrointestinal bleeding or ulcers whilst taking Reclofenac 50 mg.

NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), as their condition may get worse (see section 4).

Effects on the cardiovascular system

Medicines like Reclofenac 50 mg may be associated with a slightly increased risk of heart attack (“myocardial infarction”) or stroke. Any such risk is more likely at high doses and during prolonged treatment. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist if you have heart problems, a history of stroke or if you think that you might be at risk of such disorders (e.g. if you have high blood pressure, diabetes or high cholesterol levels, or if you smoke).

Skin reactions

Very rarely, serious skin reactions with redness and blistering, some of which were fatal, have been reported during NSAID therapy (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell’s syndrome; see section 4). The risk of such reactions appears to be highest at the start of therapy, as these reactions mostly occurred during the first month of treatment. At the first sign of skin rash, mucous membrane lesions or any other signs of a hypersensitivity reaction, you should stop taking Reclofenac 50 mg and consult your doctor immediately.

Hepatic effects

It is imperative to exercise caution (discussion with the doctor or pharmacist) before patients with hepatic dysfunction start treatment, because their condition could worsen under Reclofenac treatment. If Reclofenac 50 mg is taken for a long time, or repeatedly, regular monitoring of liver function is an appropriate precaution. If clinical signs of liver disease are found, Reclofenac 50 mg should be stopped immediately.

Impaired renal and cardiac function

Particular caution is called if you have an impaired cardiac and renal function, a history of hypertension or you are receiving diuretics.

Respiratory and allergic disorders

If you have a history of pulmonary diseases, allergies or swelling of the nasal mucosa, reactions like asthma or oedema are more likely than in other patients. In this case special precaution (readiness for emergency) is recommended.

Particularly close medical monitoring is required: – immediately after major surgery; – if you suffer from an allergy (e.g. skin reactions to other medications, asthma, hay fever), chronic nasal congestion or chronic obstructive respiratory disease – if your kidney or liver function is impaired.

Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed in very rare cases. At the first signs of a hypersensitivity reaction after taking/administering Reclofenac 50 mg, treatment must be stopped. Any treatment required must be initiated by healthcare professionals, depending on the symptoms.

Since Reclofenac can suppress signs and symptoms of an infection, including fever, it should be used with caution in patients with an infectious risk. Should you develop signs of an infection (such as redness, swelling, heat, pain and fever) or if existing signs worsen, please inform your doctor immediately.

If you are taking Reclofenac at the same time as anticoagulants (blood thinners) or antidiabetic agents (used to lower blood sugar levels), your blood clotting status/blood sugar levels should be monitored as a precaution.

During prolonged use of Reclofenac 50 mg, you should have your liver values, kidney function and blood count regularly monitored.

Whilst taking Reclofenac 50 mg, you must consult/inform your doctor or dentist before you undergo any surgery.

During prolonged use of painkillers, headache may occur, which must not be treated with increased doses of the medication. Ask your doctor for advice if – despite taking Reclofenac 50 mg – you still suffer from frequent headaches.

As a general rule, habitual intake of painkillers – particularly if several painkillers are combined – may lead to permanent kidney damage with a risk of kidney failure (analgesic nephropathy).

Children Regarding administration to children and adolescents (see also section 2 of the package insert):
– Do not take Reclofenac 50 mg –

Read the package leaflet before use. Medicinal product subject to medical prescription. To be taken as directed by the prescriber. Keep out of the reach and sight of children. Do not store above 25°C. Keep the blister in the outer carton in order to protect from moisture.

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REMAES GmbH was founded by Dr. Mamdouh Sarhan and Raoof Sarhan in April 2009 in Bremerhaven. It was then moved and settled in Hamburg, in October 2011.read more

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